Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Lauric acid
EC Number:
205-582-1
EC Name:
Lauric acid
Cas Number:
143-07-7
IUPAC Name:
lauric acid
Constituent 2
Reference substance name:
[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
IUPAC Name:
[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
Details on test material:
no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-white
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 374g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
2.5% Laurinsäure in ethanol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
2.5% Laurinsäure in ethanol
No. of animals per dose:
20
Details on study design:
The implementation of the experiment was carried out by the method of Magnusson and Kligman, the rechallenge was performed with a 2.5% lauric acid in ethanol in an occlusive form with a contact time of 24 hours.
The observation times of the maximisation procedure was 24 and 48 hours after removal of the patch.
Challenge controls:
no data

Results and discussion

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% lauric acid
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no observations
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% lauric acid. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no observations.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Lauric acid has no allergic reactions in guinea pigs.
Executive summary:

The Guinea pig maximisation test of Magnusson and Kligman was performed to reveal a possible sensitising potential of lauric acid. Investigations performed were in conformance with the OECD Guideline 406.

Ten female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. The rechallenge was performed with a 2.5% lauric acid in ethanol in an occlusive form with a contact time of 24 hours. The observation times of the maximization procedure was 24 and 48 hours after removal of the patch.

General:

All animals survived till the end of the study. No ill health or toxicity effects were noted.

Skin reactions after rechallenge:

The application sites of all control animals were normal at each time.

There were no dermal reactions seen in any of the test or control animals.

The test substance lauric acid is not sensitising.